FDA approves Cochlear's Remote Check telehealth assessment tool

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Cochlear (ASX:COH) says it has obtained US FDA approval for its Remote Check solution, the first telehealth patient assessment tool for cochlear implant recipients.

The company said Remote Check is designed to be a convenient, at-home testing tool that allows people with a Cochlear Nucleus 7 Sound Processor to complete a series of hearing checks from their compatible iOS device using the Nucleus Smart App. The results are then sent remotely to the recipient’s clinic for review by their clinician.

Cochlear said it will begin a controlled release of Remote Check in the US and intends to accelerate its release of in many countries where regulatory clearance has already been received, including Canada, the UK, and select countries in Western Europe.

Remote Check was developed to conduct routine cochlear implant checks outside the hearing clinic and following increased demand for remote care due to the COVID-19 pandemic, the FDA expedited its approval.

"Remote Check will enable hearing healthcare providers and hospitals to quickly identify those most in need of audiological care during the COVID-19 pandemic, as well as those who would benefit from Remote Check as part of their routine care over the longer-term," said Cochlear in a statement.

According to CEO and President Dig Howitt, “Remote care has been a core pillar of Cochlear’s long-term innovation strategy, with access to care crucial to people who rely on a cochlear implant. With many people around the world now practising social distancing, Remote Check provides recipients with the ability to continue to access a level of care at a time when many clinics are closed to in-person visits.

"The FDA’s expedited approval of Remote Check during the COVID-19 crisis underscores the importance of remote hearing care solutions – now more than ever – with many healthcare authorities already recognising the value in reimbursing Remote Care consultations for clinicians.”